NL-OMON41117已完成4 期
A randomized, parallel group study to evaluate the effect of Umeclidinium (UMEC) added to Inhaled corticosteroid/ long-acting beta-agonist combination therapy in subjects with Chronic Obstructive Pulmonary Disease COPD (study 201314) - study 201314
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* 40 years of age or above.
- •* An established clinical history of COPD in accordance with the definition by the ATS/ERS.
- •* Current or former cigarette smokers with a history of cigarette smoking of *10 pack-years (see protocol page 26 for details).
- •* Pre and post-salbutamol FEV1/FVC ratio of <0.70 and post-salbutamol FEV1 of *70% of predicted.
- •* Must be on the dose and frequency of one of the ICS/LABA combinations approved for COPD and for the study at least 30 days prior screening (see protocol page 26-27 for details).
- •* Score of *2 on the mMRC.
- •* Females of childbearing potential: adequate method of contraception. See protocol page 26 for details.
排除标准
- •* Hospitalization for COPD or pneumonia within 12 weeks prior to Visit 1.
- •* Lower respiratory tract infection that required the use of antibiotics within 6 weeks prior to Visit 1.
- •* Unstable or life threatening cardiac disease. See protocol page 27-28 for details.
- •* Defined prior therapies. See protocol page 28-29 for details.
- •* Pregnancy or breastfeeding
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